Navigation Links
Columbia Laboratories' NDA for PROCHIEVE® Vaginal Progesterone Gel Accepted for Filing by FDA
Date:6/27/2011

LIVINGSTON, N.J. and MORRISTOWN, N.J., June 27, 2011 /PRNewswire/ -- Columbia Laboratories, Inc. (Nasdaq: CBRX) and Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application (NDA) for PROCHIEVE® (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. The acceptance of the NDA for filing means FDA has determined that the application is sufficiently complete to permit a substantive review. The acceptance for filing does not provide any assurance that the FDA will ultimately approve the NDA.

(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO)

In addition, Columbia has voluntarily withdrawn its request for priority review. Following discussions with FDA, the companies determined that a standard review would afford the agency the appropriate timeframe necessary to complete its review of the application, including empaneling an agency advisory committee, if necessary.  Under the Prescription Drug User Fee Act III (PDUFA), the FDA's goal under standard review is to review and act on the NDA by February 26, 2012.

Under the terms of the Purchase and Collaboration Agreement between Columbia and Watson, acceptance of the PROCHIEVE NDA will trigger a $5 million milestone payment to Columbia from Watson.

"We are pleased to achieve this important regulatory milestone and look forward to working with the FDA as they review the data package for the PROCHIEVE New Drug Application," said Frank Condella, President and Chief Executive Officer of Columbia Laboratories, Inc.

"Premature birth is a critical problem in this country and currently no therapeutic option exists for preventing preterm birth in women with premature cervical shortening, an emerging risk factor," said Fred Wilkinson, Watson's Executive Vice President, Global Brands.  "The PROCHIEVE New Drug Application represents an important step in the evaluation of a potential new treatment, and if approved, could have a meaningful impact on mothers and the health of their babies, as well as a significant economic impact on the healthcare system."

Columbia submitted the NDA, which includes data from two Phase III clinical trials evaluating the use of PROCHIEVE in reducing the risk of preterm birth in women, as well as supportive pharmacokinetic studies, to the FDA on April 26, 2011.  

About Watson PharmaceuticalsWatson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.

For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

About Columbia LaboratoriesColumbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company has developed and sold six products for the U.S. market including CRINONE® (progesterone gel) for which Columbia receives royalties on annual net sales from Watson Pharmaceuticals. CRINONE is commercialized outside the U.S. by Merck Serono.

Columbia's press releases and other company information are available online at http://www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words "may," "will," "plans," "intends, " "believes," "expects," "anticipates," "potential," "could," "would," "should," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the outcome of further analyses of the clinical data generated during the PREGNANT Study by the FDA; success in obtaining timely approval of PROCHIEVE in the preterm birth indication by the FDA; the impact of competitive products and pricing; the timing and level of success of a future product launch, if any; the ability of Columbia's third-party manufacturers to supply PROCHIEVE; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; changes in the laws and regulations, including Medicaid; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; the ability to obtain and enforce patents and other intellectual property rights; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's and Watson's reports filed with the SEC, including, but not limited to, their respective Annual Reports on Form 10-K for the year ended December 31, 2010 and Quarterly Report on Form 10-Q for the period ended March 31, 2011. Neither Columbia nor Watson undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.

PROCHIEVE® and CRINONE® are registered trademarks of Watson Pharmaceuticals, Inc. For Columbia Laboratories, Inc. For Watson Pharmaceuticals, Inc.Investors  Investors Lawrence A. Gyenes
SVP, Chief Financial Officer & Treasurer
(973) 486-8860Patty Eisenhaur 
VP, Investor Relations and Corp. Comm.
(862) 261-8141--or--Media Seth Lewis
VP, The Trout Group LLC
(646) 378-2952Charlie Mayr
SVP, Corporate Affairs
(862) 261-8030MediaAmy Raskopf

President, Raskopf Communications, LLC

(917) 673-5775
'/>"/>

SOURCE Watson Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Columbia University Medical Center and Rosetta Genomics Announce Columbia Universitys Submission of the First Cancer Diagnostic Test Based on Rosetta Genomics Proprietary MicroRNA Technology for Approval to the New York State Department of Health Clinica
2. Terumo Heart, Inc. Reports Clinical Progress in the DuraHeart(TM) U.S. Pivotal Trial as NewYork-Presbyterian Hospital/Columbia University Medical Center Implants First Patient
3. Watson Confirms Columbia Laboratories Filing of Definitive Proxy Relating to Watsons Acquisition of U.S. Rights to CRINONE® Progesterone Gel Product Line
4. Watson Confirms Columbia Laboratories Shareholder Approval of Proposed Acquisition of Progesterone-related Assets
5. Watson Completes Acquisition of CRINONE® and PROCHIEVE® Product Line and Shares of Columbia Laboratories
6. HealthWarehouse.com Partners with Columbia Medical Associates to Bring Affordable Healthcare to Washington State
7. Columbia University Students Learn About Pharmacy Benefit Management From Prime Therapeutics President and CEO
8. Columbia Laboratories to Discuss Fourth Quarter and Year End 2010 Financial Results on March 10, 2011, Conference Call
9. Sanofi-aventis Enters Into Research Collaboration With Columbia University to Develop New Diabetes Treatments
10. Columbia Laboratories and Watson Announce Publication of Positive Phase III PROCHIEVE® Vaginal Progesterone Gel Study Results
11. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/17/2017)... -- MJAC2017 , the premier cannabis event devoted to ... its leading lineup. MJAC2017 is proud ... specializing in the development of pharmaceutical and consumer products, will ... The Green Organic Dutchman are gold sponsors for the event, ... ...
(Date:8/15/2017)... , Aug. 15, 2017   Mostyn Law and Gulf ... Houston, Texas . The Mostyn Law family ... 2 years. That is why Mostyn Law is partnering ... to show its appreciation. Blood supplies are running ... 5% short of hospital needs in August. That is why the ...
(Date:8/15/2017)... AccuGenomics, Inc., a diagnostic company based in ... the company has provided an AccuKit to the HIV ... Chapel Hill and to Qura Therapeutics for evaluation in ... HIV reservoir and viral expression in human CD4+ T ... Center is a joint initiative between the University of ...
Breaking Medicine Technology:
(Date:8/21/2017)... ... ... The Industrial Designers Society of America (IDSA) hosted the ... Aug. 19, 2017 in Atlanta, GA—revealing which 25 designs won Gold and which 52 ... See all the winners at http://www.idsa.org/awards/idea/gallery . , “I hope you’re as excited ...
(Date:8/20/2017)... ... August 20, 2017 , ... State Farm Neighborhood Assist® has named The ... a $25,000 grant. If the initiative wins, Gals Lead – Dream Queen Foundation’s signature ... Tri-County area of St. Mary’s, Calvert and Charles Counties. The program could potentially impact ...
(Date:8/19/2017)... ... 18, 2017 , ... Western University of Health Sciences will host a special ... new Center for Innovation on Wednesday, September 6, 2017. , The symposium will be ... by a technology exhibition from 1 to 3 p.m. showcasing virtual reality education technology, ...
(Date:8/19/2017)... New York, New York (PRWEB) , ... August ... ... Fruit Street Health has announced that it is the first organization with pending ... the CDC’s National Diabetes Prevention Program (“DPP”) via group telehealth classes and live ...
(Date:8/19/2017)... ... , ... Yesterday, the President of the United States retracted his condemnation of ... not two sides to hatred, bigotry, discrimination, and a white supremacy nationalist agenda. ... against all forms of such hatred and discrimination in this country and globally. ...
Breaking Medicine News(10 mins):